SERVICES AGREEMENT
Exhibit
4.28
AGREEMENT made
on
the 16th
day of
June, 2005 (“Effective Date”)
BETWEEN ICON
CLINICAL RESEARCH LIMITED of Xxxxx Xxxxxx Xxxxxxxx Xxxx, Xxxxxxxxxxxx, Xxxxxx
00
(hereinafter called “ICON”)
AND AMARIN
NEUROSCIENCE LIMITED of Kings Xxxx Xxxxx, Xxxxxxxxxx Xxxxxxxx Xxxx, Xxxxxxxx,
XX
XX0 0XX (hereinafter the “CLIENT”)
RECITALS:
WHEREAS
ICON is a contract research organization and is engaged in the business of
clinical trials management, monitoring and data management and of providing
expertise in such areas to the Pharmaceutical and Biotechnology industries
worldwide.
WHEREAS
the CLIENT is a limited liability company and is engaged in the development
of
pharmaceutical products.
WHEREAS
the parties
entered into a Letter of Intent dated March 9, 2005 (the “LOI”), pursuant to
which ICON agreed to provide interim services with respect to the
CLIENT’s
US
study entitled “A Multi-Center, Double-Blind, Randomized, Parallel Group,
Placebo-Controlled Trial of Miraxion (ethyl-EPA) in Patients with Mild to
Moderate Huntington’s Disease” with Protocol Number AN01.01.0011 (the “US
Study”) together with the Client’s EU study entitled” A Multi-Center,
Double-Blind, Randomized, Parallel Group, Placebo-Controlled Trial
of Ethyl-EPA (Ethyl-Icosapent) ) in Patients with Huntington’s Disease”
with Protocol Number AN01.01.0012 (the “EU Study”) , each as set out in Appendix
A (collectively
known as the “Studies” or individually a “Study)). The parties have reached
agreement on the scope of the services to be provided by ICON and other
pertinent matters, and this Agreement is the contract for services agreement
referred to in the LOI, pursuant to which ICON will render Services (defined
below).
WHEREAS
the CLIENT desires to retain ICON to provide, and ICON wishes to provide, the
services more particularly described in the Proposal set out in Appendix C,
and
incorporated as part of this Agreement (the “Services”), to the CLIENT in
connection with the Studies, subject to the terms and conditions of this
Agreement and for the purposes set out herein.
THE
PARTIES HERETO AGREE AS FOLLOWS:
1.
|
OBLIGATIONS
OF THE PARTIES:
|
1
1.1
|
Engagement
ICON shall carry out the provision of the Services in
accordance with the terms of this Agreement and the Appendices
hereto.
|
1.2
|
ICON
shall perform the Services with reasonable care and skill and shall
ensure
that personnel engaged by it in the provision of the Services are
competent and have appropriate professional qualifications, training
and
experience. All obligations which CLIENT desires to delegate to ICON
are
specified in Appendix C under Assignment of Responsibilities. Any
obligation not delegated to ICON pursuant to this Agreement and its
Appendices shall be retained by the CLIENT or as otherwise indicated
in
Appendix C. ICON acknowledges that the provision of the Services
within
the timetable set and agreed to by the parties (to include without
limitation, the timetable set out in Appendix C) is of importance
to the
CLIENT and accordingly ICON shall use all its best commercial endeavours
to meet deadlines set, by or on behalf of the CLIENT, for the provision
of
the Services.
|
1.3
|
In
performing the Services, ICON shall (where appropriate),comply with
and
shall
use all its best commercial endeavours to procure
compliance with the following:
|
1.3.1
|
the
Study Protocols and any subsequent
amendments;
|
1.3.2
|
the
ICH Harmonised Tripartite Guideline for Good Clinical Practice or
its
local equivalent (“GCP”);
|
1.3.3
|
all
applicable national and local laws, rules and regulations and those
promulgated by any relevant regulatory authority, and relevant
professional standards;
|
1.3.4
|
all
reasonable written and verbal instructions of CLIENT provided that
all
material verbal instructions of CLIENT are reduced to writing and
provided
to ICON within 3Business Days of any such verbal
instruction.
|
1.4
|
Each
party shall from time to time by notice to the other nominate a
representative(s) for primary liaison relating to the Services, which
from
the date of this Agreement shall be as
follows:
|
For
CLIENT: Xxxxx
XxXxxxxx
Clinical Project Manager
For
ICON: Xxxxxxx Xxxxxx
Clinical Project Manager
1.5
|
ICON
agrees that all personnel performing the Services shall be
employees,
contractors
or
sub-contractors of ICON and that nothing in this Agreement shall
be deemed
to create a contract of employment between CLIENT and any employee
or
sub-contractor of ICON.
|
1.6
|
ICON
agrees (provided CLIENT has given it adequate written
notice
in advance) to allow CLIENT to attend the site(s) where the Services
are
being
|
2
conducted
for the purpose of monitoring and reviewing the performance of the Services
at
times and dates mutually acceptable to all parties and to give CLIENT its
full
co-operation in this regard.
1.7
|
Changes
in Scope - The time and cost estimates contained in the Budget in
Appendix C are subject to the specific assumptions agreed to by the
parties hereto and set out therein and to the general assumptions
that the
scope of the Services do not change (the “Scope”), that nothing unforeseen
occurs which affects the budget and/or timelines and which is outside
of
the reasonable control of either party, that the CLIENT timely carries
out
its obligations under this Agreement and does nothing to prevent
or hinder
ICON from performing its obligations under this
Agreement.
|
1.8
|
In
the event that there is a change in Scope, the costs and timelines
specified in the Cost Proposal will be modified as
follows:
|
1.8.1
|
in
the event the CLIENT wishes to modify the Services or ICON identifies
a
reasonably necessary modification, the identifying party will notify
the
other of such proposed modification. ICON will then provide the CLIENT
with an estimate of the modification to the costs and
timelines;
|
1.8.2
|
the
CLIENT will then have 15 Business Days to approve or reject the proposed
modification. While the CLIENT is reviewing the proposed modification,
ICON will continue to perform its agreed-upon obligations but will
not
implement the modification.
|
1.8.3
|
should
the CLIENT reject the proposed modification the parties will use
their
best efforts to agree upon a mutually acceptable
modification.
|
1.9
|
Compliance
with Regulations - In performing the Services, ICON shall comply
with GCP,
all applicable national and local laws, rules and regulations and
those
promulgated by any relevant regulatory authority. The CLIENT will
also
comply with all such applicable laws and regulations applicable to
its
role hereunder where non-compliance would impact on ICON including,
but
not limited to, personal data protection obligations. The CLIENT
hereby agrees that ICON will not be held liable for any past performance
in the event that the clinical research and related services which
have been be performed by ICON to comply with the obligations set
forth in
this Agreement or related Protocol(s) and therefore at the CLIENT's
request, become, partly or as a whole, inconsistent with a new law or
legal obligation, rule or regulation, which would become effective
during
the performance of such research and related
services.
|
2
|
RELATIONSHIP
BETWEEN THE PARTIES:
|
2.1
|
Status
of relationship
-
Nothing in this Agreement shall be construed as creating any relationship
of partnership, joint venture or agency as and between the Parties
hereto.
|
3
2.2
|
Independent
contractors
-
No relationship of employer or employee shall arise or be created
under
this Agreement as and between the CLIENT and ICON and/or any personnel
engaged by ICON to perform the Services (the “ICON personnel”). ICON
personnel shall not be eligible for any of the CLIENT employee benefits,
nor shall the CLIENT be obliged to make any deductions from ICON’S fees
for taxes, such taxes being the sole responsibility of
ICON.
|
2.3
|
Staff
Solicitation
-
During the term of this Agreement, and for one year thereafter, (the
“Restricted Period”), each party agrees not to solicit directly any
employee of the other who has provided any of the Services or who
becomes
known to the other party by reason of this appointment, for employment
with the that party whether as an employee, independent contractor
or
otherwise. If a party breaches this provision (a “Defaulting Party”), it
agrees to pay to
the other party (a “Non-Defaulting Party”) 3
months
of the employee’s base salary, to be calculated as the base salary at the
time of employee’s departure from the Non-Defaulting Party. This payment
provision shall not apply to hiring a party’s employees who, in the
absence of solicitation, direct or indirect, by the Defaulting Party
apply
for a position with the the Defaulting Party and are hired by the
Defaulting Party, nor shall it apply to ex-employees of a party;
in each
of these cases, the party shall be free to hire without obligation
whatsoever to the Non-Defaulting Party where it is reasonable in
the
circumstances to take the view that the departure of such employee
was not
linked to the hiring by the Defaulting
Party.
|
2.4
|
ICON
Corporate Affiliates Permissible
-
The CLIENT agrees that ICON may use the services of ICON affiliates,
(each
an “ICON Affiliate”), to fulfill ICON’s obligations under this Agreement.
Any ICON Affiliate(s) so used shall be subject to all of the terms
and
conditions applicable to ICON under this Agreement and ICON shall
remain
responsible for enforcing the terms hereof and shall indemnify and
hold
harmless the CLIENT from and against all breaches of any of the terms
and
conditions of this Agreement by any ICON Affiliate. For the purposes
of
this provision, an ICON Affiliate shall mean a company, which, directly
or
indirectly, controls, is controlled by or is under common control
with
ICON. Control means ownership of fifty percent (50%) of the capital
stocks
or the voting rights of ICON, or the legal power to direct or cause
the
direction of ICON’s general management and
policies.
|
3
|
TERM
& TERMINATION
|
3.1
|
Period
of Agreement
-
The period of performance under this Agreement shall commence on
the date
of this Agreement and shall remain in force (subject to earlier
termination pursuant to Clause 3.2) until the completion of the Services
in accordance with the terms of this
Agreement.
|
3.2
|
Early
termination
-
This Agreement and any extension thereof is subject to earlier
termination:
|
4
3.2.1
|
may
be terminated in whole or in part (as to one of the two Studies)
without
cause by either party at any time during the term of the Agreement
on
sixty (60) days prior written notice to the other
party;
|
3.2.2
|
if
a
party commits any material breach of any of the provisions of this
Agreement, and, in the case of a breach capable of remedy, fails
to remedy
the same within 30 days after receipt of a written notice from the
other
party giving full particulars of the breach and confirming the intention
to terminate if not remedied. Consent to extend the remedy period
shall
not be unreasonably withheld, so long as the breaching party has
commenced
the remedy during the thirty day notice period and pursues the remedy
of
the breach in good faith;
|
3.2.3
|
if
either party shall become bankrupt or insolvent or if all or a substantial
part of its business or assets shall be placed in the hands of a
Receiver,
Administrator, Administrative Receiver, Trustee in Bankruptcy or
similar
or analogous officer or an insolvency practitioner, whether by its
voluntary act or otherwise, then this Agreement and the rights granted
herein shall immediately be subject to termination at the option
of the
other party.
|
3.3
|
Return
of materials on termination
-
Upon termination of this Agreement for any reason, ICON shall promptly
deliver to the CLIENT all documents, data and materials in whatever
form,
(including any reproductions of same) of any nature pertaining to
ICON’S
provision of Services under this Agreement and/or pertaining to any
Confidential Information as described in Clause 5. Notwithstanding
the
foregoing, ICON may retain, solely for the purpose of determining
the
scope of its obligations under this Agreement, one (1) copy of documents,
data or other materials generated
hereunder.
|
4
|
PAYMENT
|
4.1
|
Cost
of Services
-
ICON agrees, insofar as it is possible, that all of its direct costs
for
the Services are set out in the Budget at Appendix C (on the basis
that
the assumptions set out in the this Agreement as agreed by the parties
hereto are accurate) will not exceed the total sum as set out in
Appendix
C without prior written authorization from the CLIENT. CLIENT shall
pay
ICON in accordance with the budget and milestone schedule attached
hereto
as Appendices B &C and incorporated herein by reference (the
“Budget”). The parties estimate that the payments provided for in the
Budget will be sufficient to support the Studies, but ICON may submit
to
CLIENT and/or the CLIENT may request a revised budget in the event
that
costs may reasonably be projected to exceed or be less than the Budget.
Except as otherwise provided in this Agreement, CLIENT will not be
required to make any payment in excess of the Budget without CLIENT’S
prior written approval.
|
4.2
|
Fees
-
The CLIENT shall, where within the scope for the Service to be provided
for each Study, pay to ICON the Investigator fees, other out-of-pocket
costs, and ICON’s fees as are determined pursuant to clause 4.1
above.
|
5
Such
fees
and costs shall be paid in accordance the Appendix B attached hereto (Payment
Schedule)
4.3
|
Payment
for Early Termination
-
In the event this Agreement is terminated before the conclusion of
the
provision of the Services for any reason, ICON shall use its best
efforts
to reduce the cost and/or loss incurred or suffered by the CLIENT
as a
result of such early termination and: CLIENT shall
pay:
|
4.3.1
a)
|
all
fees outstanding to ICON for Services provided up to the date of
early
termination together with all reasonable costs incurred by ICON to
complete its obligations in relation to the provision of the
Services,
|
4.3.1b)
all fees and pass through costs incurred up to date of such termination together
with all future pass through costs which cannot be cancelled or
recovered.
4.4
|
Payment
terms
-
The CLIENT acknowledges that the provision of the Services pursuant
to
this Agreement is largely labor intensive and accordingly agrees
to pay
each invoice within 30 days of the date of issue. Interest will be
charged
in the amount of 1% per month (or part thereof) in respect of all
invoices
paid later than 30 days after the date of receipt of ICONs invoice
properly rendered in accordance with the terms of this Agreement
.Payment
for any services provided hereunder shall be made to ICON in GBP£ (where
relating to the E.U. Study) and in US$ (where relating to the U.S.
Study)
|
4.5
|
Float
- To ensure ICON does not suffer a cash flow depletion as a result
of the
performance of the Services, the CLIENT will provide upfront a float
of
10% from time to time of the estimated pass through costs (the “Float”).
Within 7 Business Days of the Date of this Agreement the CLIENT shall
provide to ICON a sum (representing 10% of the total
estimated pass through costs as set out in Appendix C). Thereafter,
and
subject to prior written approval in accordance with Clause 4.5 below
(where applicable), the Float may be applied to all reasonable and
necessary travel and out of pocket expenses incurred by it in the
course
of providing the Services. ICON shall issue to the Client an expense
report detailing the pass through expenses incurred and shall permit
the
CLIENT upon reasonable notice to attend the ICPN offices and audit
the
original invoices or vouchers or other evidence of actual payment
of any
such out of pocket expenses. ICON shall issue to the Client a written
request for replenishment of the Float once the initial Float is
depleted
by expenditure. For the avoidance of doubt ,upon depletion of the
Float,
the CLIENT shall within 7 Business Days of written request by ICON
the
CLIENT provide to ICON such sum as then represents 10% of the reducing
balance of the total estimated pass through costs as set out in Appendix
C. Upon the earlier of termination or expiry of this Agreement ICON
shall
with 7 Business days and without set off, deduction or counterclaim
repay
the unused balance of the Float to the
CLIENT.
|
6
4.5
|
Expenses
-
Additionally, the CLIENT shall (on the presentation of invoices or
vouchers or other evidence of actual payment) reimburse ICON for
all
reasonable and necessary travel and out of pocket expenses incurred
by it
in the course of providing the Services provided
that in the case of any individual item of expenditure exceeding
£1000,
the CLIENT’s written approval has been given for such expenditure.
Travel
expenditure shall be incurred by ICON only in accordance with pre-
agreed
travel guidelines.
|
4.6
|
Value
Added Tax (VAT)
-
unless otherwise stated, all amounts quoted in this Agreement are
exclusive of VAT which will, if required, be charged to each invoiced
amount at the appropriate rate.
|
5
|
CONFIDENTIALITY
AND DATA PROTECTION
|
5.1
|
Definition
of confidential information
-
For the purposes of this Agreement “Confidential Information” shall
mean:-
|
“Any
and
all information in whatever form pertaining to all Intellectual Property,
Know-How, trade secrets, ideas, processes, programs and all tangible and
intangible information relating to formulations, products, processes, designs,
formulas, methods, developmental or experimental work, clinical data,
improvements, discoveries, pending or potential patent claims and any
information derived therefrom, plans for research, new products, marketing
and
selling plans, business plans, budgets and unpublished financial statements,
licenses, pricing and costing information, identities of suppliers, customers
of
either party’s and information regarding the skills and compensation of
employees or other consultants of either party.”
5.2
|
Undertaking
not to disclose
-
Each party specifically undertakes and warrants that it (either by
itself
or through any of its servants or agents, or with or through any
person),
during the period of this Agreement and for a period of 7 years
thereafter, shall not use, disclose, publicize, disseminate, promote
or
advertise (other than with the prior written consent of the other
party,
or as may be required by law), any of the other party’s confidential
information as defined herein.
|
5.3
|
Exclusions
-
The obligations of the parties in Clause 5.2 shall not extend to
any
confidential information which:
|
5.3.1
|
is
or becomes generally available to the public otherwise than by reason
of a
breach by the recipient of Clause 5.2 above,
or
|
5.3.2
|
is
known to the recipient party and is at its free disposal prior to
its
receipt from the other; or;
|
5.3.3
|
is
subsequently disclosed to the recipient party without being made
subject
to an obligation of confidence by a third party;
or;
|
7
5.3.4
|
ICON
or the CLIENT may be required to disclose under any statutory, regulatory
or similar legislative requirements subject to the imposition of
the
obligations of secrecy wherever possible in that relationship;
or
|
5.3.5
|
is
disclosed by ICON to a third party to such extent only as is necessary
for
the purposes contemplated by this Agreement and subject to ICON using
all
reasonable endeavors to ensure that the person in question keeps
the same
confidential and does use the same except for the purposes for which
the
disclosure is made.
|
5.4
|
ICON
undertakes that it shall comply with the European Data Protection
Directive (95/46/EC) and take all possible measures to prevent unlawful
or
unauthorised processing of personal data when acting on CLIENT’S
behalf.
|
5.5
|
ICON
undertakes
that it shall ensure that any
contract ICON enters in to with the Investigators
or
any other relevant third party
will state
that CLIENT is the controller of personal data, and consent that
the
personal
data may be processed, disclosed or transferred and that this may
include
transference to countries both within and outside Europe where the
data
protection laws may not be as good.
|
5.6
|
Inventions
-ICON acknowledges that:
|
5.6.1
|
any
and all Intellectual Property, Know-how and Confidential Information
provided, or disclosed, to it by CLIENT is, and shall remain, the
exclusive property of CLIENT;
|
5.6.2
|
any
Intellectual property or Know-How generated during the provision
of the
Services and/or relating to the Studies shall vest in and shall be
owned
by CLIENT absolutely and shall be included in CLIENT's Intellectual
Property and Know-how.
|
and
ICON
undertakes, and undertakes to ensure that its respective directors and employees
shall undertake, to assign all right, title and interest in any Intellectual
Property or Know-How generated during the provision of the Services to CLIENT,
and ICON further undertakes to ensure that it, and its directors and employees,
shall, at CLIENT's request and expense, execute all documents and do all things
necessary to vest all right, title and interest in any such intellectual
property and know-how in CLIENT and ICON undertakes, in relation to the
provision, or disclosure, of CLIENT's Intellectual Property, Know-how and
Confidential Information, to observe its obligations of confidentiality pursuant
to Clause 5.2(Confidentiality).
5.7
|
Data
Management only: ICON Programming will evaluate requests for SAS
code on a
case by case basis. Requests for SAS code should be forwarded to
the
appropriate Department Head. Any SAS code provided will be with the
understanding that any support by ICON for the code will be considered
out
of scope unless explicitly included in the schedule of services.
All
proprietary macros will be compiled. Although the CLIENT and regulatory
authorities
|
8
will
have
permission to use the software, ICON will retain ownership of it. The CLIENT
must agree that the software will be used only on the protocol(s) for which
it
was written by ICON and will not be used for any other purpose.
5.8
|
For
the avoidance of doubt ICON shall not any time (without the CLIENT’s prior
written consent) publicly disseminate or otherwise publish any of
the
results or data arising form the Services provided hereunder or its
relationship with the CLIENT.
|
5.9
|
Cooperation
by ICON to prosecute protection - Upon the CLIENT’s request and at the
CLIENT’s expense, ICON shall execute and shall use
its best commercial endeavours procure
that any subcontractor executes such documents and take such actions
as
the CLIENT deems necessary or appropriate to obtain patent or other
proprietary protection in the CLIENT’s name concerning any of the
foregoing.
|
6
|
LIABILITY
& INDEMNITY
|
6.1
|
CLIENT
shall indemnify, defend and hold harmless ICON and its agents,
representatives, trustees, officers and employees (“ICON Indemnitees”)
from and against any demands, actions, claims, judgments or settlements
(“Claims”) that may be made or instituted against any of them (including
the reasonable attorneys’ fees and other reasonable costs and expenses of
defense), by reason of personal injury (including but not limited
to
death) or property damage to the extent it arises out of or is connected
with the performance of a Study; provided, however, that CLIENT shall
not
be liable for any loss or damage resulting from any ICON Indemnitee’s (a)
failure to adhere to the material terms of a Study or this Agreement;
and/or (b) failure to comply with any applicable regulatory or other
government requirement; (c) negligence or willful misconduct
.
|
6.2
|
ICON
agrees to indemnify and hold harmless the CLIENT and its agents,
representatives, trustees, officers and employees (the “CLIENT
Indemnitees”) from and against any Claims that may be made or instituted
against any of them (including the reasonable attorneys’ fees and other
reasonable costs and expenses of defense), by reason of personal
injury
(including but not limited to death) or property damage to the extent
it
arises out of any ICON Indemnitee’s (a) failure to adhere to the material
terms of a Study or this Agreement; and/or (b) failure to comply
with any
applicable regulatory or other government requirement; (c) negligence
or
willful misconduct.
|
6.3
|
The
indemnities above shall be subject to the following
provisions:
|
9
6.3.1
|
a
party (including its indemnities) claiming under one of the indemnities
above ( the “Indemnified Party”) shall fully and promptly inform the other
party (the “Indemnifying Party”) of any third party claim made against it
or one of its indemnities covered by the
indemnity;
|
6.3.2
|
the
Indemnified Party shall take all reasonable steps to mitigate its
loss in
relation to the indemnity;
|
6.3.3
|
the
Indemnified Party shall make no admission of liability to any third
party
in relation to any Claim made against it covered by the
indemnity;
|
6.3.4
|
the
Indemnified Party shall permit Indemnifying Party to take full control
of
such Claim or proceedings;
|
6.3.5
the
Indemnified Party shall assist in the investigation and defense of such Claim
or
proceedings.
6.4
|
ICON
warrants that it:
|
6.4.1
|
has
full capacity and capability to carry out the Services in accordance
with
the terms of this Agreement;
|
6.4.2
|
shall
use all due skill and care in the provision of the
Services;
|
6.4.3
|
shall
commit the requisite number of its appropriately skilled and qualified
employees in order to provide the Services within the timetable and
the
Budget; and
|
6.4.4
|
shall
comply with all applicable regulatory and statutory requirements
in force
which may relate to the provision of the
Services.
|
6.5
|
Exclusion
of equential loss
-
Neither party shall be liable to the other for loss, damage, or liability
in respect of loss of profits, business or revenue loss, special,
indirect
or consequential loss (even if foreseeable or in the contemplation
of
either party).
|
6.6
|
Maintenance
of insurance
-
ICON and the CLIENT shall at their own expense obtain and maintain
insurance of a type and amount adequate to cover all loss, damage,
liability or costs in respect of which it is liable to indemnify
the other
under the provisions of this clause and shall not do or omit
any act, matter or thing which may prejudice or render voidable any
such
insurance. Each party will, forthwith on request by the other, provide
the
party requesting the same with evidence of the insurance as that
party may
reasonably require.
|
7.
|
GENERAL
PROVISIONS
|
10
7.1
|
Assignment
& Sub Contracting
-
this Agreement may not be assigned by either party without the prior
written consent of the other party (such consent not to be unreasonably
withheld or delayed) provided that the CLIENT may assign this Agreement
to
any affiliated company. ICON may contract with other parties to perform
certain of the Services but shall only do so upon prior written approval
of the CLIENT as to the party involved and the terms of
appointment.
|
7.2
|
Good
Faith
-
Each party will act in good faith in its performance of this Agreement
and
will not unreasonably delay or withhold the giving of any consent,
decision or approval that is either requested or reasonably required
by
the other party in order to perform its responsibilities under this
Agreement.
|
7.3
|
Notices
-
any notice or other communication to be given under this Agreement
shall
be delivered personally or sent by first-class pre-paid post or facsimile
transmission (confirmed by first-class pre-paid post) addressed as
follows:
|
If
to the
CLIENT to:
General
Counsel & Company Secretary
Amarin
Neuroscience Limited
c/o
Amarin Corporation plc
Curzon
Street
Mayfair
London
Fax
No.
x00 (0) 00 0000 0000
If
to
ICON to:
Xxxxx
Xxxx
ICON
Clinical Research UK Limited
Concept
House
0
Xxxxxxxxxxx Xxxx
Xxxxxxxxx
Xxxx, Xxxxxxxxx
Xxxxxxxxx,
XX00 0XX
Fax
No:
+44 (2380) 688501
With
a
copy to:
Legal
Department
ICON
Clinical Research Limited
Xxxxx
Xxxxxx Xxxxxxxx Xxxx
Xxxxxxxxxxxx
Xxxxxx
00
or
to
such other designation as either party may hereafter notify to the
other
in accordance with other provisions in this clause.
11
7.4
|
All
such notices or other communications shall be deemed to have been
served
as follows:
|
(a)
|
If
delivered personally, at the time of such delivery,
or;
|
(b)
|
if
sent by first-class pre-paid post, three business days (Saturday,
Sundays
and Bank or other public holidays excluded) after being placed in
the
post.
|
7.5
|
Modification
& Waiver
-
no modification of this Agreement shall be deemed effective unless
in
writing and signed by each of the parties hereto, and no waiver of
any
right set forth herein shall be deemed effective unless in writing
and
signed by the party against whom enforcement of the waiver is
sought.
|
7.6
|
Survival
-
the expiration or earlier termination of this Agreement, (howsoever
caused) shall not affect any of the terms, provisions, representations
or
warranties hereof which are expressed to continue after such expiration
or
termination, nor shall any such expiration or termination affect
the
rights or obligations of either party hereto in respect of any antecedent
breach of this Agreement.
|
7.7
|
Severability
-
if any of the provisions of or a portion of any of the provisions
of this
Agreement is held to be unenforceable or invalid by a court of competent
jurisdiction, the validity and enforceability of the enforceable
portion
of any such provision and/or the remaining provisions shall not be
affected thereby.
|
7.8
|
Entire
Agreement
-
this Agreement incorporates Appendices A ,B and C - hereto which
together
represents the entire Agreement between the parties and supersedes
all
prior negotiations, representations or agreements, written or oral
relating to the subject matter hereof but without prejudice to any
rights
which may have already accrued thereunder to either
party.
|
7.9
|
Force
Majeure
-
neither party shall be liable for any failure to perform or delay
in
performing any obligations under this Agreement if such failure or
delay
is due to fire, flood, earthquake, strike or any other industrial
disturbance, war (declared or undeclared), embargo, blockade, legal
prohibition, regulatory delays, drug delays, riot, insurrection or
any
other cause beyond the control of such defaulting party preventing
or
delaying the performance of such obligations; provided that such
obligations shall be performed immediately upon the termination of
such
cause and provided further that in the event of such failure or delay
continuing for more than two (2) months either party may, without
incurring liability to the other, terminate this Agreement immediately
by
written notice to the other party.
|
7.10
|
Governing
Law
-
this Agreement shall in all respects (including the formation thereof
and
performance thereunder), be governed by and construed in accordance
with
the laws for the time being in force in England and the parties hereto
hereby submit to the exclusive jurisdiction of the English
courts.
|
12
7.11
|
Counterparts
-
this Agreement may be executed in 2 counterparts each of which shall
be
deemed an original, but both of which together shall constitute one
and
the same instrument.
|
8.
|
definitions
and interpretation
|
8.1
|
Definitions-
In this Agreement the following expressions shall have the following
meanings namely:
|
“Agreement”
means this service agreement including the Appendices hereto;
“Business
Day(s)” means a day, other
than Saturday or Sunday, on which the clearing banks are generally open for
business in Scotland
or
Ireland;
"Intellectual
Property" means all Know-how and existing and future intellectual and industrial
property rights including, but not limited to, patents, design rights (whether
registered or unregistered), trade marks (whether registered or unregistered)
and any applications therefor, copyright, know-how and Confidential
Information;
"Know-how"
means all secret and confidential ideas, concepts, unpatentable inventions,
drawings, models, specifications, formulae, data, processes, procedures,
techniques and any other technical and financial information or documentation
relating to Product or CLIENT's (and or any company affiliated with the
CLIENT)business or business activities;
8.2
|
Interpretation-
Save to the extent that the context or the express provisions of
this
Agreement require otherwise, in this
Agreement:-
|
8.2.1
|
words
importing the singular shall include the plural and vice
versa;
|
8.2.2
|
words
importing any gender shall include all other
genders;
|
8.2.3
|
any
reference to Recital, Clause, Appendix or Part of the Appendix is
to a
relevant recital, clause Appendix or part of the schedule of or to
this
Agreement;
|
8.2.4
|
references
to this Agreement or any other document shall be construed as references
to this Agreement or to that other document as modified, amended,
varied,
supplemented, assigned, novated or replaced from time to
time;
|
8.2.5
|
references
to any statute or statutory provision (including any subordinate
legislation) includes any statute or statutory provision which amends,
extends, consolidates or replaces the same, or which has been amended,
extended, consolidated or replaced by the same, and shall include
any
orders, regulations, instruments or other subordinate legislation
made
under the relevant statute or statutory
provision;
|
13
8.2.6
|
any
phrase introduced by the words “including”, “include”, “in particular” or
any similar expression shall be construed as illustrative only and
shall
not be construed as limiting the generality of any preceding
words;
|
8.2.7
|
any
reference to a party to this Agreement includes that party’s permitted
successors, transferees and
assignees;
|
8.3
|
Headings
|
The
headings in this Agreement are included for convenience only and shall be
ignored in construing this Agreement.
IN
WITNESS WHEREOF the
parties hereto have caused this Agreement to be duly executed by their
authorised representatives as of the dates written below.
AMARIN
NEUROSCIENCE LIMITED ICON
CLINICAL RESEARCH LIMITED
Signed______________________
Signed______________________
Title________________________ Title________________________
Date________________________ Date________________________
14